Johnson & Johnson MedTech · 6 days ago
Quality Engineer I- Shockwave Medical
Santa Clara, CA
Full-time
Onsite
New Grad, Entry Level
$62K/yr - $100K/yrJohnson & Johnson is a leader in healthcare innovation, seeking a Quality Engineer I to support Quality Assurance Design Development activities related to IVL catheters. This role involves collaborating with internal stakeholders to identify risks and improvement opportunities while ensuring compliance with applicable quality and regulatory standards.
Hospital & Health Care
Responsibilities
Perform biannual updates to commercial Risk Management Files using post market surveillance data
Review/approve complaints and ensure accurate linkages to associated risks in products Risk Management Files
Review/approve clinical annual updates (e.g. LSP, LSR, PMCFP, CEP, CER)
Participate in data integrity initiative for Verification & Validation activities. Review test and inspection data to ensure compliance with Good Documentation Practices (GDP)
Audit data collection processes for GDP compliance
Collect, Prepare, and present risk management data to management representatives prior to periodical management review
Familiarity with inspection and functional testing using various measurement systems per specifications test protocols
Audit Design History Files (DHFs) for Design Control procedure compliance
Author technical documentation with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence (e.g. inspection/testing procedures, development studies, verification/validation protocols and reports, quality plans)
Review, investigate, disposition, and close Non-conforming Reports (NCR) or Corrective and Preventive Actions (CAPA) as assigned
Initiate, review, and approve Document Change Orders (DCO)
Use statistical tools and software (e.g. Minitab) to perform process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, and variable and attribute sampling plans
Demonstrate and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team
Demonstrate teamwork, integrity, and commitment to patient safety and product quality
Adhere to company policies, quality systems, and regulatory requirements
Perform other duties as assigned
Qualification
Required
BS in a related engineering discipline (Mechanical, Electrical, Biomedical or equivalent)
Strong technical writing and verbal skills are required
Proactive, self-motivated and able to work with moderate supervision as responsibilities grow
Able to work in the Controlled Environment Room (CER)
Some travel may be required
Effective communication skills with peers and direct levels of management
May be required to lift objects up to 25 lbs
Ability to read and interpret technical specifications and mechanical drawings
High attention to detail and accuracy is required
Proficiency in MS Word, MS Excel and MS Power Point required
Operate with adaptability to changing requirements
Able to work in a fast-paced environment, managing multiple priorities
Preferred
Some related experience is preferred
Internship, co-op, or relevant coursework in the medical device industry is preferred
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
Founded in 1886
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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